Proportion of participants with clinically relevant changes in ACQ-5 score from baseline (improved, no difference, worsened) by visit and end of study, PRACTICAL
| Visit | Budesonide–formoterol ‘as needed’, n (%) | Budesonide maintenance two times per day N (%) | ||||||
| N | Improved | No difference | Worsened | N | Improved | No difference | Worsened | |
| Visit 2 (Week 4) | 423 | 111 (26.2) | 253 (59.8) | 59 (14.0) | 427 | 128 (30.0) | 254 (59.5) | 45 (10.5) |
| Visit 3 (Week 16) | 409 | 126 (30.8) | 226 (55.3) | 57 (13.9) | 399 | 144 (36.1) | 209 (52.4) | 46 (11.5) |
| Visit 4 (Week 28) | 389 | 132 (33.9) | 202 (51.9) | 55 (14.1) | 377 | 130 (34.5) | 199 (52.8) | 48 (12.7) |
| Visit 5 (Week 40) | 377 | 126 (33.4) | 196 (52.0) | 55 (14.6) | 367 | 132 (36.0) | 193 (52.6) | 42 (11.4) |
| Visit 6 (Week 52)* | 403 | 143 (35.5) | 200 (49.6) | 60 (14.9) | 406 | 158 (38.9) | 196 (48.3) | 52 (12.8) |
| End of study (LCOF)† | 434 | 154 (35.5) | 214 (49.3) | 66 (15.2) | 431 | 169 (39.2) | 207 (48.0) | 55 (12.8) |
Categories are based on the MCID for ACQ-5 and are defined as follows: improved (≤−0.5); no change (>0.5 to <0.5), worsened (≥0.5).
*Visit 6 represents ACQ-5 scores collected at withdrawal from the study or at completion of the study (week 52).
†LOCF except if only a baseline reading was available; the number missing any observations after baseline was 3 for budesonide–formoterol ‘as needed’ 17 for budesonide maintenance two times per day.
ACQ-5, Asthma Control Questionnaire Version 5; LOCF, last observation carried forward; MCID, minimal clinically important difference; N, number of patients in each treatment group at each visit; n, number of patients in each ACQ-5 category.